First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
This study is the first time a new cancer medicine called OVM-200 will be tested in people. It's for patients aged 18-75 with prostate, non-small cell lung, or ovarian cancer. The main goal is to see if OVM-200 is safe and to find the best dose to use. We'll also look at how it affects cancer and if there are any side effects. Patients will receive three injections over four weeks and then be monitored for about six months. This trial is an important step to see if OVM-200 could become a helpful treatment in the future.
At a glance
What is this study about?
This study is about a new medicine called OVM-200. It's designed to work like a cancer vaccine, helping your body's immune system to fight cancer. This is the very first time OVM-200 will be given to people, so it's a very early-stage trial.
The study will involve up to 52 patients, aged between 18 and 75, who have prostate, non-small cell lung, or ovarian cancer. The main aim is to carefully check if OVM-200 is safe to use and to find the right dose. We'll also start to get an idea of how well it works against these cancers and what side effects it might have. This early research is crucial to decide if OVM-200 should be studied further as a potential new treatment.
The study is divided into two main parts. In the first part, small groups of patients will receive increasing doses of OVM-200 to find the safest and most effective dose. Once that dose is found, more patients will receive it in the second part to confirm its safety and learn more about its effects on their cancer. The study will take place in around five hospitals across the UK.
Key takeaways
- A brand new cancer medicine (OVM-200) is being tested for the first time in people.
- It's for prostate, non-small cell lung, or ovarian cancer patients.
- The main aims are to test its safety and find the right dose.
- Participants will receive three injections over about four weeks.
- The total study time is around six months, with ten hospital visits.
Who may be eligible?
To be considered for this study, you need to have prostate, non-small cell lung, or ovarian cancer that has spread or can't be removed by surgery. You should have already tried at least one standard cancer treatment. For prostate cancer, you might be on ongoing hormone therapy. For other cancers, you might be in a stable period after finishing a course of treatment, or have run out of other standard treatment options. You also shouldn't be receiving other active cancer treatments at the time of joining the study, unless it's supportive care or ongoing hormone therapy for prostate cancer.
There are also some general health requirements. You need to be between 18 and 75 years old, have a reasonable level of fitness (meaning you can generally manage daily tasks), and be expected to live for at least another three months. Your organs, like your bone marrow, kidneys, and liver, need to be working well. If you have non-small cell lung cancer, your cancer must have at least one measurable spot that can be tracked with scans like CT or MRI.
On the other hand, you would not be able to join if you have a known history of severe immune system problems or certain autoimmune diseases that need specific medication. If you've recently taken strong steroid medicines or other drugs that weaken your immune system, you also wouldn't be eligible. Some milder conditions like vitiligo or well-managed diabetes or psoriasis generally wouldn't stop you from joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged between 18 and 75 years old.
- I have prostate, non-small cell lung, or ovarian cancer that has spread or can't be removed by surgery.
- I have already received at least one standard cancer treatment.
- I am generally well and able to manage most daily activities.
- I am not currently taking strong immune-suppressing medicines (like high-dose steroids).
What does participation involve?
If you decide to take part and are found to be suitable after some initial checks, you will receive three doses of OVM-200. These will be given as an injection under the skin every two weeks. After your last dose, you will be carefully monitored for any side effects and to see how your cancer is responding. In total, you would be involved in the study for about six months. During this time, you would have ten hospital visits for check-ups and assessments. The study team will explain everything in detail if you are interested.
Potential risks and benefits
Locations (4)
- University College London Hospitals NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
- Sarah Cannon Research Institute UKVerified postcodeLondon, United Kingdom· Recruiting
- The Christie NHS Foundation TrustVerified postcodeManchester, United Kingdom· Recruiting
- Oxford University Hospitals NHS Foundation TrustVerified postcodeOxford, United Kingdom· Not yet recruiting
Common questions
What kind of cancer is this study for?
This study is for people with prostate, non-small cell lung, or ovarian cancer that has spread or can't be operated on.
How is OVM-200 given?
OVM-200 is given as an injection under your skin, similar to some vaccinations.
How long will I be in the study if I take part?
You will be in the study for about six months in total, with ten planned visits to the hospital.
What is a 'Phase 1' study?
A Phase 1 study is the first step in testing a new medicine in people. Its main goal is to check if the medicine is safe and to find the best dose to use.
Can I still take my regular cancer treatments?
You can generally continue supportive care or hormone therapy for prostate cancer. However, most other active cancer treatments would need to be stopped before joining the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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